Effect of Transcutaneous Auricular Stimulation of the Vagus Nerve on Functional Connectivity in the Brain at Rest

NCT07282106 | Completed

• 2 other identifiers: 2025-A01694-4525.03521.000408
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to study the effect of Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) on resting-state brain functional connectivity. The study will assess this effect using functional Near-Infrared Spectroscopy (fNIRS) in both chronic post-stroke patients and healthy subjects. The main questions it aims to answer are: Does taVNS affect resting-state functional connectivity (measured by fNIRS) in chronic post-stroke patients? Does taVNS affect resting-state functional connectivity (measured by fNIRS) in healthy subjects? Are there differences in the effect of taVNS on functional connectivity between the post-stroke group and the healthy group? Researchers will compare the effect of active taVNS (real stimulation) to a sham stimulation (control) to evaluate its specific impact on the brain's functional networks.

Conditions

Chronic Stroke Patients

Keywords

fNIRS; taVNS; stroke; functional brain connectivity; resting state; healthy people

Outcome Measures

Primary Outcomes (1)

• Resting-State Functional Connectivity

  Day 1

Study Arms (2)

Active taVNS arm

EXPERIMENTAL

Transcutaneous Auricular Vagus Nerve Stimulation (taVNS): Delivery of low-intensity electrical impulses to the outer ear (concha and tragus) to stimulate the auricular branch of the vagus nerve.

Device: Active taVNS arm

Sham Control arm

SHAM COMPARATOR

Simulated/Placebo Stimulation (Sham): Application of the device without delivering an active electrical current, serving as the necessary control condition.

Device: Sham Control arm

Interventions

Active taVNS arm DEVICE

Transcutaneous Auricular Vagus Nerve Stimulation (taVNS): Delivery of low-intensity electrical impulses to the outer ear (concha and tragus) to stimulate the auricular branch of the vagus nerve.

Active taVNS arm

Sham Control arm DEVICE

Simulated/Placebo Stimulation (Sham): Application of the device without delivering an active electrical current, serving as the necessary control condition.

Sham Control arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age 18 or older
• Right-handed participant;
• Hemiparesis in the chronic phase (\>6 months post-stroke)
• Participant who has agreed to sign an informed consent form;
• Participant who is affiliated with social security.
• age 18 or older
• Right-handed participant;
• Participant who has agreed to sign an informed consent form;
• Participant who is affiliated with social security.

You may not qualify if:

• Allergy to neoprene (the material used to make the fNIRS cap);
• Hair volume preventing the cap from being put on and/or access to the scalp;
• Cognitive impairment making it impossible to participate in the study;
• Phasic disorders preventing understanding of instructions and effective communication;
• Pregnant or breastfeeding women;
• Persons under legal protection
• Allergy to neoprene (the material used to make the fNIRS cap);
• Hair volume preventing the cap from being put on and/or access to the scalp;
• Pregnant or breastfeeding women;
• Persons under legal protection

Sponsors & Collaborators

• Clinique Les Trois Soleils: lead

Study Sites (1)

Clinique Les Trois Soleils

Boissise-le-Roi, 77310, France

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2025
• First Posted: December 15, 2025
• Study Start: December 8, 2025
• Primary Completion: February 5, 2026
• Study Completion: February 5, 2026
• Last Updated: March 17, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)